Arterial HypertensionSOPHOCLESNCT06589947
StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation
A study testing Standard Treatment in people with Arterial Hypertension and Kidney Transplant; Complications, run by Hannover Medical School.
Trial summary
Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Arterial Hypertension, Kidney Transplant; Complications
- What is being tested?
- Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Kidney transplantation \>12 months ago
- Arterial hypertension
Who cannot join
- Cardiac malformation
- Treatment for a rejection episode within three months prior to inclusion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. AH can cause left ventricular hypertrophy (LVH), which is predictive of CV death. LVH can be non-invasively assessed by measuring left ventricular mass index (LVMI). Analyses of observational data showed that blood pressure (BP) levels <75th percentile (pct) were associated with a significant reduction of LVMI. Guidelines give BP goals for children with chronic kidney disease (CKD). No guidelines, however, exist on the treatment of AH in pediatric KTx patients. In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation we aim to assess n=500 pediatric patients >12 months after KTx at several KTx centers. Patients will be randomly assigned 1:1 to an intensified BP management group (BP target ≤60th pct) and a standard BP management group (BP target <90th pct). The primary endpoint is LVMI after 24 months. Secondary endpoints are estimated glomerular filtration rate (eGFR), pulse wave velocity (PWV) and intima media thickness (IMT) after 24 months. BP control will be guaranteed for both groups through BP telemonitoring, which will be transmitted in real time to the treating physician and the trial's centralized BP office. By defining the adequate BP goal, the results of the proposed study will have direct implications for the care of children after KTx. The results will define an important element of post-KTx care and help to lower CV morbidity and subsequently CV mortality of pediatric KTx patients.
- Being tested
- Intensified BP control, Standard Treatment
- Keywords
- Left ventricular mass, Pediatric kidney transplantation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified BP controlOther
Treatment goal in the intensified group will be lowering BP ≤60th pct.
Standard TreatmentOther
Standard treatment is to achieve BP levels \<90th pct.
| Study group | Role | What they receive |
|---|---|---|
| Standard BP group | Active comparator | The treatment goal for the standard group is to achieve BP levels <90th pct. Receives: Other: Standard Treatment |
| Intensified BP group | Experimental | Treatment goal in the intensified group will be lowering BP ≤60th pct. Receives: Other: Intensified BP control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass index (LVMI)
LVMI at 24 months after randomization. Echocardiography will follow a standardized operating procedure established during the 4C study in accordance with the American Society of Echocardiography guidelines. LVMI will be calculated by dividing left-ventricular mass in grams (according to Devereux) by height in meters to the 2.16th with a correction factor of 0.09.
Measured: At 24 months after randomization
Secondary outcomes (3)
Pulse Wave velocity (PWV)
PWV at 24 months after randomization.
Measured: At 24 months after randomization
Estimated Glomerular Filtration Rate (eGFR)
eGFR estimated by the Schwartz bedside formula at 24 months after randomization.
Measured: At 24 months after randomization
Intima Media Thickness (IMT)
IMT at 24 months after randomization. IMT will be assessed using ultrasound with a high-resolution linear probe, by averaging five measurements from the far wall of the common carotid artery 1-2 cm proximal of the carotid bulb, following the Mannheim consensus.
Measured: At 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2024 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Berlin; Charité, Bonn; Kindernieren-zentrum Bonn, University Hospital, Essen, Frankfurt; Clementine Kinderhospital, Universitätsklinikum Hamburg-Eppendorf, Stuttgart; Olgahospital, Hacettepe University, Vienna; University Hospital Vienna
- Responsible party
- Principal investigator, Prof. Dr. Dr. Anette Melk, Hannover Medical School
- Investigators
- Anette Melk, MD PhD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589947
- Sponsor's protocol ID
- SOPHOCLES
- Acronym
- SOPHOCLES
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grabitz C, Memaran N, Sugianto RI, von der Born J, Bukova M, Lehmann E, Konuhov AK, Holzwart D, Grosshennig A, Wuhl E, Schmidt BMW, Melk A. StOPping Hypertension and imprOving Children's Lives after KidnEy TranSplantation (SOPHOCLES): study protocol for a randomized controlled multicenter trial. Trials. 2025 Aug 27;26(1):315. doi: 10.1186/s13063-025-09033-z.
PubMed 40866927
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation
- ClinicalTrials.gov ID
- NCT06589947
- Acronym / sponsor ID
- SOPHOCLES / SOPHOCLES
- Keywords
- Left ventricular mass, Pediatric kidney transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Heidelberg University, Berlin; Charité, Bonn; Kindernieren-zentrum Bonn, University Hospital, Essen, Frankfurt; Clementine Kinderhospital, Universitätsklinikum Hamburg-Eppendorf, Stuttgart; Olgahospital, Hacettepe University, Vienna; University Hospital Vienna
- Study start
- 16 Sep 2024 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. AH can cause left ventricular hypertrophy (LVH), which is predictive of CV death. LVH can be non-invasively assessed by measuring left ventricular mass index (LVMI). Analyses of observational data showed that blood pressure (BP) levels <75th percentile (pct) were associated with a significant reduction of LVMI. Guidelines give BP goals for children with chronic kidney disease (CKD). No guidelines, however, exist on the treatment of AH in pediatric KTx patients. In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation we aim to assess n=500 pediatric patients >12 months after KTx at several KTx centers. Patients will be randomly assigned 1:1 to an intensified BP management group (BP target ≤60th pct) and a standard BP management group (BP target <90th pct). The primary endpoint is LVMI after 24 months. Secondary endpoints are estimated glomerular filtration rate (eGFR), pulse wave velocity (PWV) and intima media thickness (IMT) after 24 months. BP control will be guaranteed for both groups through BP telemonitoring, which will be transmitted in real time to the treating physician and the trial's centralized BP office. By defining the adequate BP goal, the results of the proposed study will have direct implications for the care of children after KTx. The results will define an important element of post-KTx care and help to lower CV morbidity and subsequently CV mortality of pediatric KTx patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard BP group | Active comparator | Other: Standard TreatmentThe treatment goal for the standard group is to achieve BP levels <90th pct. |
| Intensified BP group | Experimental | Other: Intensified BP controlTreatment goal in the intensified group will be lowering BP ≤60th pct. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Kidney transplantation \>12 months ago
- Arterial hypertension
Key exclusion criteria (2 listed)
- Cardiac malformation
- Treatment for a rejection episode within three months prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified BP controlTreatment goal in the intensified group will be lowering BP ≤60th pct. | Other | Intensified BP group |
| Standard TreatmentStandard treatment is to achieve BP levels \<90th pct. | Other | Standard BP group |
Primary outcome
Left ventricular mass index (LVMI)
Time frame: At 24 months after randomization
LVMI at 24 months after randomization. Echocardiography will follow a standardized operating procedure established during the 4C study in accordance with the American Society of Echocardiography guidelines. LVMI will be calculated by dividing left-ventricular mass in grams (according to Devereux) by height in meters to the 2.16th with a correction factor of 0.09.
3 secondary outcomes
Pulse Wave velocity (PWV)
Time frame: At 24 months after randomization
Estimated Glomerular Filtration Rate (eGFR)
Time frame: At 24 months after randomization
Intima Media Thickness (IMT)
Time frame: At 24 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40866927Grabitz C, Memaran N, Sugianto RI, von der Born J, Bukova M, Lehmann E, Konuhov AK, Holzwart D, Grosshennig A, Wuhl E, Schmidt BMW, Melk A. StOPping Hypertension and imprOving Children's Lives after KidnEy TranSplantation (SOPHOCLES): study protocol for a randomized controlled multicenter trial. Trials. 2025 Aug 27;26(1):315. doi: 10.1186/s13063-025-09033-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anette Melk, MD PhD principal investigator
Hannover Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Standard Treatment in people with Arterial Hypertension and Kidney Transplant; Complications, run by Hannover Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anette Melk, MD PhD (+49 511 532 0 ext. 5597, sophocles@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular mass index (LVMI) (time frame: At 24 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.